Study on Sequential Immunization of Inactivated COVID-19 Vaccine and Recombinant COVID-19 Vaccine (Ad5 Vector) in Elderly Adults

NCT ID: NCT04952727

Last Updated: 2022-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-26
• Study Completion Date: 2022-05-15

Brief Summary

This is a randomized, observer-blind, parallel-controlled study, for evaluation of safety and immunogenicity of sequential immunization of a recombinant COVID-19 vaccine (adenovirus type 5 vector) in Chinese healthy adults aged 60 and above after the priming vaccination of inactivated vaccine. 300 healthy subjects aged 60 and above will be recruited in this study. Of them, 200 subjects who have been vaccinated with two dose of inactive SARS-CoV-2 vaccine will be recruited and randomized at a 1:1 ratio to receive a booster dose of inactivated SARS-CoV-2 vaccine or recombinant SARS-CoV-2 Ad5 vectored vaccine at 3~6 months later. Other 100 subjects who have been vaccinated with one dose of inactivated SARS-CoV-2 vaccine will be recruited and randomized at a 1:1 ratio to receive a booster dose of inactivated SARS-CoV-2 vaccine or recombinant SARS-CoV-2 Ad5 vectored vaccine at 1~3 months later. The occurrence of adverse events within 28 days and serious adverse events within 6 months after vaccination will be observed. In addition, blood samples will be collected on day 0 before the boosting with ad5 vectored vaccine and on day 14, 28 and month 6 after the boosting. Serum antibody levels, cellular immune responses and the subgroups or germlines of the specific B cells will be analyzed. Each subject will remain in this study for approximately 6 months.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

heterologous boost arm with Ad5 vectored vaccine

Subjects who have been primed with two doses of inactive SARS-CoV-2 vaccine will receive a booster of recombinant SARS-CoV-2 Ad5 vectored vaccine after 3\~6 months.

Group Type: EXPERIMENTAL

Recombinant SARS-CoV-2 Ad5 vectored vaccine

Intervention Type: BIOLOGICAL

This vaccine contains 5×10\^10 virus particles of recombinant replication defective human type 5 adenovirus expressing SARS-CoV-2 S protein, which is produced by CanSino Biologics Inc. It is a liquid dosage form, 0.5 ml / bottle.

homogeneous boost arm with inactive vaccine

Subjects who have been primed with two doses of inactive SARS-CoV-2 vaccine will receive a booster dose of inactive SARS-CoV-2 vaccine after 3\~6 months.

Group Type: ACTIVE_COMPARATOR

Inactive SARS-CoV-2 vaccine (Vero cell)

Intervention Type: BIOLOGICAL

This vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research \& Development Co., Ltd. 0.5 ml / bottle.

heterologous regimen with Ad5 vectored vaccine

Subjects who have been primed with one dose of inactive SARS-CoV-2 vaccine will receive one dose of recombinant SARS-CoV-2 Ad5 vectored vaccine after 1\~3 months

Group Type: EXPERIMENTAL

Recombinant SARS-CoV-2 Ad5 vectored vaccine

Intervention Type: BIOLOGICAL

This vaccine contains 5×10\^10 virus particles of recombinant replication defective human type 5 adenovirus expressing SARS-CoV-2 S protein, which is produced by CanSino Biologics Inc. It is a liquid dosage form, 0.5 ml / bottle.

homogeneous regimen arm with inactive vaccine

Subjects who have been primed with one dose of inactive SARS-CoV-2 vaccine will receive one dose of inactive SARS-CoV-2 vaccine after 1\~3 months.

Group Type: ACTIVE_COMPARATOR

Inactive SARS-CoV-2 vaccine (Vero cell)

Intervention Type: BIOLOGICAL

This vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research \& Development Co., Ltd. 0.5 ml / bottle.

Interventions

Recombinant SARS-CoV-2 Ad5 vectored vaccine

This vaccine contains 5×10\^10 virus particles of recombinant replication defective human type 5 adenovirus expressing SARS-CoV-2 S protein, which is produced by CanSino Biologics Inc. It is a liquid dosage form, 0.5 ml / bottle.

Intervention Type: BIOLOGICAL

Inactive SARS-CoV-2 vaccine (Vero cell)

This vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research \& Development Co., Ltd. 0.5 ml / bottle.

Intervention Type: BIOLOGICAL

Other Intervention Names

Ad5-nCoV; CoronaVac

Eligibility Criteria

Inclusion Criteria

• Health subjects aged 60 and above, who have been completed two-dose regimen of inactive SARS-CoV-2 vaccine in the past 3-6 months, or received one dose of inactive SARS-CoV-2 vaccine in the past 1-3 months.
• The subject can provide with informed consent and sign informed consent form (ICF).
• The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the 6-month follow-up of the study.
• Axillary temperature ≤ 37.0#.
• Individuals who are in good health condition at the time of entry into the trial as determined by medical history, physical examination and clinical judgment of the investigator and meet the requirements of immunization

Exclusion Criteria

• have the medical history or family history of convulsion, epilepsy,encephalopathy and psychosis.
• be allergic to any component of the research vaccines, or used to have a history of hypersensitivity or serious reactions to vaccination.
• women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan within six months.
• have acute febrile diseases and infectious diseases.
• have severe chronic diseases or condition in progress cannot be controlled.
• congenital or acquired angioedema / neuroedema
• have the history of urticaria 1 year before receiving the investigational vaccine.
• have asplenia or functional asplenia.
• have thrombocytopenia or other coagulation disorders (which may cause contraindications for intramuscular injection).
• have needle sickness.
• have the history of immunosuppressive therapy, anti-allergy therapy,cytotoxic therapy or inhaled corticosteroids (excluding corticosteroidspray therapy for allergic rhinitis, and acute corticosteroid therapy without dermatitis) over the past 6 months.
• have received blood products within 4 months before injection of investigational vaccines.
• under anti-tuberculosis treatment.
• not be able to follow the protocol, or not be able to understand the informed consent according to the researcher's judgment, due to variousmedical, psychological, social or other conditions.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CanSino Biologics Inc.

INDUSTRY

Sponsor Role: collaborator

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jing-Xin Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Provincial Center for Diseases Control and Prevention

Locations

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, China

Countries

China

References

Jin PF, Guo XL, Gou JB, Hou LH, Song ZZ, Zhu T, Pan HX, Zhu JH, Shi FJ, Du P, Huang HT, Liu JX, Zheng H, Wang X, Chen Y, Wan P, Wu SP, Wang XW, Xu XY, Yan FR, Li JX, Chen W, Zhu FC. Immunogenicity and safety of heterologous immunisation with Ad5-nCOV in healthy adults aged 60 years and older primed with an inactivated SARS-CoV-2 vaccine (CoronaVac): a phase 4, randomised, observer-blind, non-inferiority trial. Lancet Reg Health West Pac. 2023 Jun 20;38:100829. doi: 10.1016/j.lanwpc.2023.100829. Online ahead of print.

Reference Type: DERIVED

PMID: 37360864 (View on PubMed)

Other Identifiers

JSVCT117

Identifier Type: -

Identifier Source: org_study_id